Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer

Lung Cancer Clinical Trial

— Telocap02  

Official title:

Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846103
• Other study ID #: P/2013/207
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: September 14, 2023

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.

Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: September 14, 2023
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer)

• stade IIIb or metastatic

• Patient candidate to a first-line therapy

• Performance status 0, 1 or 2 on the ECOG scale

• Written informed consent

Exclusion Criteria:

• History of adjuvant chemotherapy for lung cancer treatment

• Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone = 10 mg/day is allowed)

• Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years

• Active autoimmune diseases, HIV, hepatitis C or B virus

• Patients with any medical or psychiatric condition or disease,

• Patients under guardianship, curatorship or under the protection of justice.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Biological samples
blood and tumor tissue samples

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	Centre Georges François Leclerc	Dijon
France	CHU de Dijon	Dijon
France	Institut Jean Godinot	Reims
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (2)

Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619. doi: 10.4161/onci.21513. — View Citation

Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillere B, Tartour E, Borg C, Adotevi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	time between the date of initiation of treatment and the date of death from any cause	date of death from any cause (within 2 years after the initiation of the treatment)
Secondary	UCP-specific Th1 responses measured by ELISPOT assay		up to 12 months
Secondary	Progression free survival	time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause.	date of first progression of the disease (within 2 years after the initiation of the treatment)
Secondary	quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries.		from the inclusion to patient death, up to 2 years